Merck Receives EU’s CHMP Positive Opinion for its Zerbaxa (ceftolozane and tazobactam) and Keytruda (pembrolizumab) + Inlyta (axitinib) Regimen

 Merck Receives EU’s CHMP Positive Opinion for its Zerbaxa (ceftolozane and tazobactam) and Keytruda (pembrolizumab) + Inlyta (axitinib) Regimen

Merck’s Receives EU’s CHMP Positive Opinion for its Zerbaxa (ceftolozane and tazobactam) and Keytruda (pembrolizumab) + Inlyta (axitinib) Regimen

Shots:

  • The positive CHMP opinion of Zerbaxa (3gm) is based on P-III ASPECT-NP study assessing Zerbaxa in patients with hospital-acquired pneumonia including ventilator-associated pneumonia. The EC will review CHMP’s opinion to grant centralized marketing authorization to the combination therapy
  • The CHMP positive opinion of Keytruda + Inlyta is based on P-III KEYNOTE 426 study which demonstrated improvement in PFS, OS, ORR regardless of PD-L1 expression compared to Sunitinib with its expected EC marketing authorization approval in Q3’19
  • Zerbaxa (IV) is antibacterial combination therapy with its supplemental MAA under regulatory review in multiple countries including Canada & Japan. Keytruda is a mAb targeting PD-1 and blocking its interaction with PD-L1 and PD-L2 thereby activating T-lymphocytes affecting both tumor and healthy cells

Click here, Click here to­ read full press release/ article | Ref: Merck | Image: Twitter

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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